Senior Quality Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

Senior Quality Engineer

Working at Abbott

The Opportunity

Abbott Rapid Diagnostics (formerly Alere) is part of Abbott’s Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies. The position of Senior Quality Engineer is within our Toxicology Business Unit located at Instant Technologies, Inc. in Portsmouth, Virginia (also supporting Norfolk, Virginia location). In this role, you will be responsible for identifying, leading and/or supporting quality, regulatory and compliance improvement initiatives; execute highly complex or specialized projects; adapt precedent and may make significant departures from traditional approaches to develop solutions. Responsible for designing and maintaining programs for the systematic monitoring and evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met.

What You’ll Work On

• Responsible for overseeing and instructing, directing and checking the work of operations staff.

• Responsible for application of quality principles and complex analysis of quality records, reports to form recommendations for improvements.

• Document quality issues and performance measures for management review.

• Lead and/or contribute to quality system alignment, product/service, metrics and process improvement projects.

• Act as quality assurance subject matter expert for support of validation and qualification activities, facilitating the application of validation/change controls, risk management, quality planning and implementation of validation or qualification plans.

• Supports development and review of validation and qualification plans and test scripts.  May support projects in multiple quality systems.

• Works closely with facilities, commercial, supply chain, information technology, operations, and sister site SMEs to prevent non-conformities and provide solutions to complex issues.

• Support multiple projects, balancing priorities and resources to meet project and management expectations. 

• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. 

• Demonstrates good judgement in selecting methods and techniques for obtaining solutions.

• Serve as documentation and change control SME and support the change control process by reviewing proposed changes, performing risk assessments and assessing the adequacy of verifications and validations.

• Lead and support the QI and CAPA processes by performing investigations and root cause analysis and determining action plans and driving the actions to closure.

• Perform root cause analysis of quality issues.  Apply appropriate tools (e.g., statistics, fault tree analysis, etc.). Work with peers to develop corrective actions.

• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.

• Carries out duties in compliance with established business policies.

• Demonstrates commitment to the development, implementation and effectiveness of the Quality Management System per ISO, FDA and other regulatory agencies.

• Understands and is aware of the quality consequences which may occur from the improper performance of their specific job.

• Other duties as assigned.

Required Qualifications

• Bachelor’s degree or related equivalent experience

• Minimum of +5 years of experience in Quality Assurance activities in a medical device or pharmaceutical industries, or within a related industry or role with exposure to quality practices and quality processes

• Prior supervisory or management experience with responsibility for project delivery

• Industry experience in managing document control processes and software

• Thorough knowledge and practical application of Quality System Regulations or other applicable regulatory area or standard scheme

• Ability to articulate complex quality and regulatory matters with persons of a variety of backgrounds

• Must have capability to review, analyze, summarize and interpret quality systems data, draw conclusions, make appropriate decisions and recommendations, write reports and best practices and give oral presentations

Preferred Qualifications

• Master’s degree preferred

• Strong analytical, written, people-influencing and verbal communication skills

• Effective organizational and time management skills

• Must show strong self-initiative and be comfortable in the role of a team player 

• Must be able to work independently with minimal supervision

• Prior experience with FDA or related audits

• Supervisory experience is also preferred

• ASQ Certification or equivalent is beneficial

COMPETENCIES:

• Analytical skills (e.g., statistical, risk analysis, root cause analysis)

• Leadership

• Team player

• Interpersonal skills

• Drives for results

• High level of attention to detail

• Collaboration

The base pay for this position is

$85,300.00 – $170,700.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:Operations Quality

DIVISION:TOX ARDx Toxicology

LOCATION:United States > Portsmouth : 1342 Court Street

ADDITIONAL LOCATIONS:

WORK SHIFT:Standard

TRAVEL:Not specified

MEDICAL SURVEILLANCE:Not Applicable

SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf